This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research is to evaluate the effectiveness of electrical stimulation in the brain for the treatment for Parkinson's disease (PD). PD is a disorder of the nervous system that affects the ability to move. Patients may develop slowed movements, stiff limbs and shaking of the hands. The disease worsens over time, and patients may gradually lose the ability to walk, to use their arms and hands, and to take care of themselves. Patients may also experience milder changes in memory, attention, and mood. Both pallidotomy and DBS have been shown to improve the movement problems in patients with PD. DBS has the advantage that it does not involve the destruction of brain cells in order to provide effective treatment. There have not, however, been detailed studies examining whether there are differences in the effectiveness of DBS in GPi as compared to DBS in STN. Furthermore, it has not been determined whether DBS can be effective when only side of the brain is stimulated (unilateral DBS) or whether it is necessary to simulate both sides of the brain (bilateral DBS). The effectiveness of DBS has not been carefully compared to that of pallidotomy. Finally, the long -term effects of DBS have not been examined. The main purpose of this study is to perform a systematic research study comparing these different surgical treatments. A major interest is whether the effectiveness is different for DBS in STN as compared with DBS in GPi. In order to investigate this question, we will perform detailed evaluations of patients with severe PD who have been treated with once of the following 4 options: unilateral DBS in STN, unilateral DBS in GPi, bilateral DBS, and unilateral pallidotomy combined with unilateral DBS. Patients will receive detailed evaluations of their movement symptoms, their functional abilities, their mood, and their memory. These evaluations will be performed during 3-day visits in the Cleveland Clinic GCRC occurring one month before surgery (baseline) and at 6 months following surgery, 12 months following surgery, and then annually. All patients who agree to participate in the study will sign an informed consent form that describes what is involved in their participation in the research, including the possible treatments they may receive, the nature of the evaluations, and the risks associated with participation in the study. The outcomes of this research will advance our understanding of the best approaches for treating patients with severe PD. Because all patients will receive detailed evaluation, the research findings may suggests characteristics of patients (e.g., age, overall severity of PD, major PD symptom) that may predict which treatment will be most effective for a particular patients. The study will examine not only the short-term effects of the surgery but also long-term effects that may occur several years after the surgery has been performed. The research will contribute to our understanding of how PD affects the nervous system and my suggest additional approaches for treating this disease.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR018390-04
Application #
7377712
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
4
Fiscal Year
2006
Total Cost
$106,620
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Other Basic Sciences
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
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